This invention relates to the field of medical prostheses, particularly to the field of urological prostheses, and more particularly to the field of penile implants.
There are numerous physiological causes of male impotence. For example, diseases such as diabetes and multiple sclerosis and trauma caused by injury or surgery can damage nerves or blood vessels that are necessary for tumescence. Drugs and advanced age may also cause impotence.
Numerous external devices (e.g., vacuum systems) and internal devices have been proposed to overcome impotence so that an erection can be achieved and maintained. Various surgical techniques for implanting such internal devices have become wellknown. Internal and external devices for dealing with impotence, surgical techniques for implanting such internal devices, and other urological prostheses are disclosed in U.S. Pat. Nos. 5,063,914, 5,050,592, 4,881,531, 4,875,472, 4,807,608, 4,791,917, 4,790,298, 4,693,719, 4,669,456, 4,619,251, 4,611,584, 4,545,081, 4,541,420, 4,522,198, 4,517,967, 4,411,261, 4,378,792, 4,342,308, 4,318,396, 4,187,839, 4,151,841, 4,151,840, 4,005,699; and in R. T. Bergman et al., "Plastic Reconstruction of the Penis," J. Urol., vol. 59, pp. 1174-1182 (1948); R. Hrebinko et al., "Early Experience with the Duraphase Penile Prosthesis," J. Urol., vol. 143, pp. 60-61 (1990); J. N. Kabalin et al., "Infectious Complications of Penile Prosthesis Surgery," J. Urol., vol. 139, pp. 953-955 (1988); J. J. Kaufman et al., "Complications of Penile Prosthesis Surgery for Impotence," J. Urol., vol. 128, pp. 1192-1194 (1982); R. Kessler, "Complications of Inflatable Penile Prostheses," Urology, vol. 18, pp. 470-472 (1981); J. N. Krieger et al., "Size Considerations for Custom Penile Prostheses," J. Urol., vol. 144, pp. 1482-1483 (1990); K. Levinson et al., "Omniphase Penile Prosthesis: Delayed Bilateral Central Cable Breakage," J. Urol., vol. 141, pp. 618-619 (1989); J. J. Mulcahy et al., "Duraphase Penile Prosthesis-- Results of Clinical Trials in 63 Patients," J. Urol., vol. 143, pp. 518-519 (1990); J. J. Mulcahy, "The Self-Contained Inflatable and Mechanical Penile Prosthesis," AUA Update Series, vol. 6, lesson 20 (1987); P. W. Nadig et al., "Noninvasive Device to Produce and Maintain an Erection-Like State," Urology, vol. 17, pp. 126-131 (1986); J. E. Oesterling, "A Simple Technique for Removal of Eroded Penile Prostheses," J. Urol., vol. 142, pp. 1538-1539 (1989); E. A. Tanagho et al. (eds.), Contemporary Management of Impotence and Infertility, pp. 191-200 (1988); P. C. Walsh et al. (eds.), Campbell's Urology, vol 1, pp. 700-735 (5th ed., 1986); S. K. Wilson et al., "Eleven Years of Experience with the Inflatable Penile Prosthesis," J. Urol., vol. 139, pp. 951-952 (1988); R. Witherington, "Vacuum Constriction Device for Management of Erectile Impotence," J. Urol., Vol. 141, pp. 320-322 (1989); Mentor Corporation brochure, "Vacuum Constriction Devices," 2 pages (June 1990); Mentor Corporation brochure, "ACU-FORM.TM. Penile Prosthesis," 2 pages (May 1991); Mentor Corporation brochure, "Malleable Penile Prosthesis," 2 pages (November 1990); Mentor Corporation brochure, "Mark II Inflatable Penile Prosthesis," 2 pages (May 1990); Mentor Corporation brochure, "Mark II Inflatable Penile Prosthesis," 2 pages (January 1991); Mentor Corporation brochure, "ALPHA I.RTM. Inflatable Penile Prosthesis," 2 pages (May 1991); American Medical Systems brochure, "Dynaflex-- Fit for Performance: A Review of the Results and Mechanics of the Dynaflex.TM. Penile Prosthesis," 3 pages (1990); American Medical Systems brochure, "700 ULTREX.TM. Penile Prosthesis," 4 pages (1990); American Medical Systems brochure, "A Brief Guide to Your Choices for Impotence Treatment," 4 pages (1989); Osborn Medical Systems brochure, "Impotence-- The Non-Surgical Solution," 2 pages (1989); Osborn Medical Systems brochure, "Impotence-- When you want a non-surgical solution, there's only one ... ," 4 pages (1990); American Medical Systems brochure, "AMS 700 CX.TM. Inflatable Penile Prosthesis," 2 pages (1988); Brochure for Third Edition of Urogynecology and Urodynamics: Theory and Practice by D. R. Ostergard et al., 2 pages (no date); Medical Engineering Corp. poster, "SURGITEK-- Innovators Not Imitators" (1988); and F. Hinman, Jr., Atlas of Urologic Surgery, pp. 103-116 (1989).
The use of coils (usually in the form of springs) in penile implants is disclosed in some of those documents. See, e.g., U.S. Pat. Nos. 5,063,914, 4,881,531, 4,875,472, 4,807,608, 4,790,298, 4,693,719, 4,669,456, 4,619,251, 4,545,081, 4,541,420, 4,522,198, 4,517,967, 4,342,308, 4,187,839, and Mentor Corporation brochure, "Malleable Penile Prosthesis," 2 pages (November 1990). The use of magnets in penile implants is disclosed in some of those documents. See, e.g., U.S. Pat. Nos. 4,791,917, 4,411,261, 4,378,792, 4,342,308, 4,318,396, and 4,005,699. U.S. Pat. No. 4,342,308 uses both magnets and springs. Squeezing the outside of the device (after implantation) to activate and/or deactivate it is disclosed in some of those documents, e.g., U.S. Pat. No. 4,875,472; E. A. Tanagho et al. (eds.), Contemporary Management of Impotence and Infertility, p. 198 (1988); and American Medical Systems brochure, "Dynaflex-- Fit for Performance: A Review of the Results and Mechanics of the Dynaflex.TM. Penile Prosthesis," 3 pages (1990). Use of a constriction band is disclosed in some of those documents, e.g., R. Witherington, "Vacuum Constriction Device for Management of Erectile Impotence," J. Urol., vol. 141, pp. 320-322 (1989).
All of the documents identified in this application, including all of the foregoing, are incorporated by reference herein in their entirety for all purposes.
The devices used internally are surgically implanted in the corpora cavernosa (one device or part of a two-housing device in each corpus cavernosum) and typically have biocompatible material on their outer surfaces. One class of device pressurizes fluid to expand and rigidify the device, which in turn rigidifies each of the corpora cavernosa and, therefore, the penis. These devices have the advantage of more closely simulating nature (by allowing movement between flaccid and erect states) than the older devices that contain a solid relatively inflexible elongate bar of material within each housing. Those devices not using fluid include the previously mentioned devices containing a solid relatively inflexible rod or bar, devices containing an elongate malleable rod or bar, and devices containing an articulated or segmented elongate member. Such devices are disclosed in the above-identified documents, and all of these devices have their disadvantages.
The drawbacks of the pressurized fluid devices include possible fluid leakage and pump and valve failure, any of which typically necessitates corrective surgery. The drawbacks of the inflexible rod, flexible rod, and articulated devices are also well-known and usually include the inability to be reduced in length to any significant extent when not in use and the resulting poor concealability.
Accordingly, there is a continuing need for penile implants that avoid the problems of the fluid devices and also avoid the problems of the known non-fluid devices.